Fortune Examines Challenges for Over-The-Counter Approval of OraQuick Oral HIV TestFortune magazine in its May 29 edition examines the challenges OraSure Technologies faces in obtaining FDA approval for over-the-counter sales of its oral OraQuick Advance Rapid HIV 1/2 Antibody Test, which some analysts predict might not happen for 18 months (Simons, Fortune, 5/29). The OraQuick test requires users to swab their gums and then place the swab in a holder. After 20 minutes, one line appears on the strip if the test result is negative and the person is HIV-negative, and two appear if the result is positive and the person is HIV-positive. Positive results require a follow-up test with a medical professional for confirmation (Kaiser Daily HIV/AIDS Report, 4/12). OraSure in December 2005 experienced a "setback" in its bid for OTC sales of OraQuick when some of the tests administered in Los Angeles, New York City and San Francisco gave false positive results, Fortune reports. FDA determined the false positives were the result of a failure by health workers administering the tests to follow its instructions (Fortune, 5/29).
Clinical Studies, Follow-Up Needed
The FDA Blood Products Advisory Committee at a March hearing told OraSure it needs to devise a clinical study to test the accuracy and safety of OraQuick before moving forward with the approval process. The committee recommended a multiple-phase experiment of at-home HIV tests that explores whether people could perform the test correctly and what psychological risks exist for those who test HIV-positive (Kaiser Daily HIV/AIDS Report, 4/2). According to Fortune, FDA is likely to require that the studies determine "what kind of written directions offer the best guidance, especially for less educated users or those for whom English is a second language." In addition, OraSure also must show FDA it has a "follow-up strategy" for people who test positive that includes counseling and referrals, according to Fortune. OraSure CEO Douglas Michels said he is petitioning health care companies for assistance (Fortune, 5/29).